ANDA 085941

CHARTWELL RX

FDA Drug Application

Application #085941

Application Sponsors

ANDA 085941

CHARTWELL RX

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

35MG

0

PHENDIMETRAZINE TARTRATE

PHENDIMETRAZINE TARTRATE

FDA Submissions

	ORIG	1	AP	1983-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-09-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-06-27
LABELING; Labeling	SUPPL	7	AP	1989-01-26
LABELING; Labeling	SUPPL	8	AP	1989-12-13
LABELING; Labeling	SUPPL	9	AP	1991-08-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-10-06

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	13	Null	0

CDER Filings

CHARTWELL RX

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85941
            [companyName] => CHARTWELL RX
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENDIMETRAZINE TARTRATE","activeIngredients":"PHENDIMETRAZINE TARTRATE","strength":"35MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PHENDIMETRAZINE TARTRATE","submission":"PHENDIMETRAZINE TARTRATE","actionType":"35MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)